DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer

The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between do

Trial Details

NCT ID
NCT06275958
Phase
PHASE3
Sponsor
Leiden University Medical Center
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Doublet Chemotherapy, Standard Dose (100%)
  • Doublet Chemotherapy, Dose-reduced (75%)
  • Monotherapy, Standard Dose (100%)
  • Monotherapy, Dose-reduced (75%)
Locations (sample)
  • 's-Hertogenbosch, Netherlands|51.69917,5.30417
  • Alkmaar, Netherlands|52.63167,4.74861
  • Amstelveen, Netherlands|52.30083,4.86389
  • Amsterdam, Netherlands|52.37403,4.88969
  • Arnhem, Netherlands|51.98,5.91111

Key Eligibility Criteria

  • Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options.
  • Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist
  • Being able to understand the Dutch language
  • Adequate bone marrow and organ function: Absolute neutrophil count (ANC) \> 1.5 x 10\^9 mmol/L, Hemoglobin (Hb) \> 6.0 mmol/L, Platelets \>100 x 10…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Colorectal Cancer Trials on Trialify →